BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM

K060569 · Ortho Development Corp. · JWH · Jul 6, 2006 · Orthopedic

Device Facts

• Record ID: K060569
• Device Name: BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
• Applicant: Ortho Development Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Balanced Knee® System Revision is intended for cemented use only in knee arthroplasty procedures whose indications include: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Moderate valgus, varus, or flexion deformities. 6. Revision procedures where other treatments or devices have failed The Balanced Knee® System Revision is indicated in the salvage of previously failed surgical attempts where femoral bone loss may require the use of augments or stem extensions.

Device Story

Balanced Knee System Revision is a semiconstrained cemented knee prosthesis; used in total knee arthroplasty and revision procedures. Device addresses joint function loss, arthritis, and failed prior surgeries; includes components for femoral bone loss management (augments, stem extensions). Implanted by orthopedic surgeons in hospital/surgical settings. Provides mechanical replacement of knee joint surfaces to restore mobility and reduce pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semiconstrained cemented knee prosthesis; metal/polymer construction. Includes femoral augments and stem extensions for bone loss. Class II device (Product Code JWH).

Indications for Use

Indicated for patients requiring knee arthroplasty due to loss of joint function, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or moderate valgus/varus/flexion deformities. Also indicated for revision procedures and salvage of failed surgical attempts involving femoral bone loss requiring augments or stem extensions. Cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2006

Mr. William J. Griffin Manager, Regulatory & Clinical Affairs Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

Re: K060569

> Trade/Device Name: Balanced Knee System Revision Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 27, 2006 Received: June 29, 2006

Dear Mr. Griffin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the iddinetions for use stated in the enclosure) to legally marketed predicate devices marketed in intentate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling. and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your deville can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. IDA max publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other mequirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. William J. Griffin

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1000. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use of Device Form

K060569 510(k) Number (if known):

Device Name: Balanced Knee® System Revision

Indications for Use

The Balanced Knee® System Revision is intended for cemented use only in knee arthroplasty procedures whose indications include:

- 1. Loss of joint configuration and joint function.
- 2. Osteoarthritis of the knee joint.
- 3. Rheumatoid arthritis of the knee joint.
- 4. Post-traumatic arthritis of the knee joint.
- 5. Moderate valgus, varus, or flexion deformities.
- 6. Revision procedures where other treatments or devices have failed

The Balanced Knee® System Revision is indicated in the salvage of previously failed surgical attempts where femoral bone loss may require the use of augments or stem extensions.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

shatter fracture

510(k) Number K061061